Marketing authorization
Marketing Authorization is a procedure that has become widespread in most countries of the world, under the control of the States, to guarantee the safety and efficacy of medicines for patients, from their conception to their withdrawal from the market (notion of life cycle). Medicines, before being introduced on the European or French market, must receive a marketing authorization. A drug is legally defined as: Certain claims or therapeutic allegations put forward for certain cosmetic products or food supplements may therefore earn their owners the anger of the regulatory authorities. Marketing authorization is the culmination of a long process to design a safe and effective medicine. This process usually takes about 15 years. Exploratory research combines, for the chemical drug, the synthesis of multiple variations from the same basic skeleton or the reuse of existing molecules in databases. The molecules most likely to give a pharmacological action are selected either by testing in vitro, in vivo (cell models) or in silico (computer models, based on docking or QSAR studies). Following this screening, only a hundred or so molecules are eligible to start pharmacological trials. In the end, only one will be left for the marketing authorization application! Phase I: tolerance + metabolism: Phase II: efficacy and optimal dose: Phase III: efficacy and safety: During the marketing phase, a "pharmacovigilance" mechanism is put in place: potential side effects are collected from health professionals and may lead to observational studies. In addition, interventional studies (known as phase IV) may be carried out, particularly if the marketing authorization so requires, because of the small number of patients during clinical trials. These studies are carried out under conditions similar to usual care, with the aim of identifying any rare adverse effects not detected during the previous phases (pharmacovigilance) and specifying the conditions of use for certain groups of patients at risk. This phase makes it possible to analyse drug interactions and encourages the development of new galenic forms and extensions of therapeutic indications. During the marketing phase, secondary clinical studies may be conducted at the initiative of the manufacturer to test the drug on another disease, a new population, as part of a new therapeutic strategy, etc., to authorize a new indication. Bibliography, to find out more: (1) https://www.sedlex.fr/brevets-en-france/la-procedure-amm-et-les-ccp/ (2) Public Health Code [i] Quantitative Structure-Activity RelationshipA guarantee of safety and efficacy for patients
Main stages in the design of a medicinal product before marketing authorization.
In general terms, the main stages in the life of a drug from conception to marketing are as follows. (1)
Next come the preclinical trials and the clinical trials. (1)
The purpose of preclinical trials is to check the tolerance of molecules in vitro in animals, to carry out toxicological tests and to study the pharmacokinetics of molecules (basically, to see how quickly the molecules act, are absorbed or are eliminated).
Clinical research (approximately 7 years of work) is divided into three main phases: